Appalachian State University Research Protections and Institutional Review Board
Standard Operating Procedures
SOP #4
Revision 1
TITLE: IRB Review of Modifications and
Addendums
Date Effective:
Revision Date: 11/23/2015
Approved By:
RP Director Date: 11/23/2015
Approved By:
IRB Chair
PURPOSE
Date: 11/23/2015
To describe the procedures for conducting reviews of modifications and addendums for approved human subject research.
GENERAL DESCRIPTION
Principal Investigators (PI) are responsible for requesting IRB review of proposed changes to approved human subject research. Changes in research procedures or consent/assent forms may not be initiated without IRB approval, except when necessary to eliminate apparent immediate hazards to the subject. Research procedures approved by the IRB may be conducted while the
IRB reviews a modification request. In accordance with federal regulations and institutional policy, the IRB conducts substantive and meaningful review of proposed changes to an IRB approved study.
RESPONSIBILITY
Execution of SOP: Principal Investigator (PI)/Study Personnel, Research Protections (RP) Staff,
IRB administrators, IRB Chair.
PROCEDURES
Modification and Addendum IRB Review (MOD) requests
1.
Research Protection (RP) staff maintain an IRB website with instructions for requesting changes to approved human subject research.
2.
The Principal Investigator (PI) must submit a MOD request for proposed changes to an approved research protocol and/or informed consent form/process prior to implementing changes, except when necessary to eliminate apparent hazards to subjects. In cases where changes are made to eliminate apparent hazards to subject(s), the PI must inform the IRB Chairperson or Director of RP as soon as possible and request IRB review of the
MOD request.
3.
A complete MOD request includes: a.
a modification and/or addendum application which explains the nature of the modification (i.e., change that impacts overall protocol), exception (i.e., change

SOP #4
Revision # 1
Appalachian State University and Institutional Review Board
Standard Operating Procedures
TITLE: IRB Review of Modifications and Addendums
Page: 2 of 3 that impacts individual subjects and does not change the overall protocol), or deviation (i.e., a departure from the protocol), b.
revised applications, consent forms, and other applicable materials with proposed changes highlighted, and c.
data safety monitoring reports, if applicable. d.
For minor personnel changes*, RP staff may consider notification from the PI
(and faculty advisor) sufficient for a MOD request.
4.
Upon receipt of a review request, RP staff: a.
enter the request in an IRB management system, b.
acknowledge receipt of the request through an email to all research personnel designated to receive correspondence on the IRB application, c.
confirm whether research personnel have completed any IRB mandated training, and d.
confirm that the request is complete.
5.
If a MOD request is incomplete, RP staff notifies the PI (any research personnel designated to receive correspondence on the IRB application) via email. If the request remains incomplete after 45 days, RP staff notifies the PI that the request will be withdrawn if the MOD request is not completed within 7 days.
6.
If the MOD request includes a new unanticipated problem/adverse event, RP staff separate the problem/adverse event report and process the report using standard procedures.
7.
An IRB administrator screens complete MOD requests to determine the level of review: exempt, expedited or full board and follow appropriate review procedures. If an IRB administrator is unable to determine the level of review (e.g., cannot determine if a study is minimal risk), the IRB Chairperson determines the level of review.
a.
MOD requests for a study voted more than minimal risk which include only incidental changes (other than personnel), and do not affect the procedures in a significant manner or increase participant risk, may be approved without full board review under the following condition: A decision to approve the changes must be made by the IRB Chair, the IRB Administrator, and one voting member of the IRB unanimously agreeing. The IRB would be provided a summary of the decision at the next convened meeting.
*Minor Personnel Change
Minor personnel changes are changes in study personnel (e.g., adding and removing students and staff), and personnel who do not have overall responsibility for the study (e.g., PI, co-
Investigator, senior Research Personnel) or responsibilities which do not require a specific expertise (e.g., conducting blood draws).

Appalachian State University and Institutional Review Board
Standard Operating Procedures
SOP #4
Revision # 1
TITLE: IRB Review of Modifications and Addendums
INSTITUTIONAL REVIEW
Page: 3 of 3
A research application may require institutional review in addition to IRB review (e.g.,
Institutional Biosafety Council; Radiation Safety Council; Conflict of Interest review). The PI is responsible for informing RP staff about the need for any other institutional reviews. RP staff coordinates additional required reviews to ensure that the research is not conducted until all required reviews have been completed and approved.
SUPPORT PROCESSES AND PROCEDURES
IRB SOPs
REFERENCES
45 CFR Part 46.103(b)(4)(i), 21 CFR 56.108(a)(1)&(2), 21 CFR 56.109(f), 21 CFR 56.110, 21
CFR 56.111, 21 CFR 56.115(a)(3)&(7), 45 CFR 46.103(b)(4), 45 CFR 46.108(b), 45 CFR
46.109(e), 45 CFR 46.110, 45 CFR 46.111, 45 CFR 46.115(a)(3)&(7), 45 CFR 46.103(a), 21
CFR 56.103(a), and 38 CFR 16.103(a)